Baxter Infusion Pump Recalled for Incomplete Post-Repair Testing
Baxter Healthcare is recalling certain infusion pumps that were released after repair without complete testing. Incomplete testing could affect how the device delivers medication to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device released without complete post-repair testing. No illnesses or injuries have been reported, but incomplete testing of an infusion pump presents a significant risk of malfunction and improper medication delivery.
Plain-English summary
Baxter Healthcare Corporation is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8), Product Code 35700BAX2. The recalled pumps were released after repair without full testing being performed, which includes flow testing.
Flow testing is critical to ensure infusion pumps operate correctly and deliver medications at prescribed rates. Pumps released without complete post-repair testing may not function as intended, posing a risk to proper medication delivery.
These devices were distributed in the United States. Healthcare facilities and medical professionals using these pumps should contact Baxter Healthcare Corporation for information regarding this recall.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- incomplete-testing
- malfunction
- medication-delivery-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 00085412498683
- Serial Number: 2153638
Distribution
Distributed nationwide across the United States.
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